EP1663229B1 - Pharmazeutische kombinationen von hydrocodon und naltrexon - Google Patents

Pharmazeutische kombinationen von hydrocodon und naltrexon Download PDF

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Publication number
EP1663229B1
EP1663229B1 EP04788669A EP04788669A EP1663229B1 EP 1663229 B1 EP1663229 B1 EP 1663229B1 EP 04788669 A EP04788669 A EP 04788669A EP 04788669 A EP04788669 A EP 04788669A EP 1663229 B1 EP1663229 B1 EP 1663229B1
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EP
European Patent Office
Prior art keywords
hydrocodone
naltrexone
pharmaceutically acceptable
acceptable salt
pharmaceutical composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP04788669A
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English (en)
French (fr)
Other versions
EP1663229A4 (de
EP1663229A2 (de
Inventor
Benjamin Oshlack
Curtis Wright
Chris Breder
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Euro Celtique SA
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Euro Celtique SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from PCT/US2004/029521 external-priority patent/WO2005032555A2/en
Priority to PL04788669T priority Critical patent/PL1663229T3/pl
Priority to SI200431458T priority patent/SI1663229T1/sl
Priority to EP10159824A priority patent/EP2298303A1/de
Priority to EP04788669A priority patent/EP1663229B1/de
Application filed by Euro Celtique SA filed Critical Euro Celtique SA
Publication of EP1663229A2 publication Critical patent/EP1663229A2/de
Publication of EP1663229A4 publication Critical patent/EP1663229A4/de
Publication of EP1663229B1 publication Critical patent/EP1663229B1/de
Application granted granted Critical
Priority to CY20101100649T priority patent/CY1110207T1/el
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
    • A61P25/36—Opioid-abuse

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  • Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Addiction (AREA)
  • Epidemiology (AREA)
  • Psychiatry (AREA)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (19)

  1. Eine pharmazeutische Zusammensetzung umfassend etwa 5 mg Hydrocodon oder ein pharmazeutisch annehmbares Salz davon und 0,0625 mg Naltrexon oder ein pharmazeutisch annehmbares Salz davon.
  2. Eine pharmazeutische Zusammensetzung umfassend etwa 7,5 mg Hydrocodon oder ein pharmazeutisch annehmbares Salz davon und 0,09375 mg Naltrexon oder ein pharmazeutisch annehmbares Salz davon.
  3. Eine pharmazeutische Zusammensetzung umfassend etwa 10 mg Hydrocodon oder ein pharmazeutisch annehmbares Salz davon und 0,125 mg Naltrexon oder ein pharmazeutisch annehmbares Salz davon.
  4. Eine pharmazeutische Zusammensetzung umfassend etwa 15 mg Hydrocodon oder ein pharmazeutisch annehmbares Salz davon und 0,1875 mg Naltrexon oder ein pharmazeutisch annehmbares Salz davon.
  5. Eine pharmazeutische Zusammensetzung umfassend etwa 20 mg Hydrocodon oder ein pharmazeutisch annehmbares Salz davon und 0,25 mg Naltrexon oder ein pharmazeutisch annehmbares Salz davon.
  6. Die pharmazeutische Zusammensetzung nach einem der Ansprüche 1-5 weiterhin umfassend einen Trägerstoff zur verzögerten Freisetzung, der eine verzögerte Freisetzung des Hydrocodons oder des pharmazeutisch annehmbaren Salzes davon bereitstellt.
  7. Die pharmazeutische Zusammensetzung nach einem der Ansprüche 1-5 weiterhin umfassend einen Trägerstoff zur verzögerten Freisetzung, der eine verzögerte Freisetzung des Naltexons oder des pharmazeutisch annehmbaren Salzes davon bereitstellt.
  8. Die pharmazeutische Zusammensetzung nach einem der Ansprüche 1-5 weiterhin umfassend einen Trägerstoff zur verzögerten Freisetzung, der eine verzögerte Freisetzung des Hydrocodons oder des pharmazeutisch annehmbaren Salzes davon und des Naltexons oder des pharmazeutisch annehmbaren Salzes davon bereitstellt.
  9. Die pharmazeutische Zusammensetzung nach Anspruch 6 und 8, wobei die Dosierungsform eine wirksame Schmerzlinderung für mindestens 12 Stunden nach oraler Verabreichung im Fließgleichgewicht an menschliche Patienten bereitstellt.
  10. Die pharmazeutische Zusammensetzung nach Anspruch 6 und 8, wobei die Dosierungsform eine wirksame Schmerzlinderung für mindestens 24 Stunden nach oraler Verabreichung im Fließgleichgewicht an menschliche Patienten bereitstellt.
  11. Die pharmazeutische Zusammensetzung nach Anspruch 8, wobei das Hydrocodon oder das pharmazeutisch annehmbare Salz davon und das Naltrexon oder das pharmazeutisch annehmbare Salz davon im Wesentlichen in besagtem Trägerstoff zur verzögerten Freisetzung ineinander dispergiert sind.
  12. Die pharmazeutische Zusammensetzung nach den Ansprüchen 1-5, wobei besagtes Hydrocodon in Form des Bitartratsalzes vorliegt.
  13. Die pharmazeutische Zusammensetzung nach den Ansprüchen 1-5, wobei besagtes Naltrexon in Form des Hydrochloridsalzes vorliegt.
  14. Die pharmazeutische Zusammensetzung nach den Ansprüchen 1-13, weiterhin umfassend ein nicht-steroidales entzündungshemmendes Mittel ausgewählt aus der Gruppe bestehend aus Ibuprofen, Diclofenac, Naproxen, Benoxaprofen, Flurbiprofen, Fenoprofen, Flubufen, Ketoprofen, Indoprofen, Piroprofen, Carprofen, Oxaprozin, Pramoprofen, Muroprofen, Trioxaprofen, Suprofen, Aminoprofen, Tiaprofensäure, Fluprofen, Bucloxinsäure, Indomethacin, Sulindac, Tolmetin, Zomepirac, Tiopinac, Zidometacin, Acemetacin, Fentiazac, Clidanac, Oxpinac, Mefenaminsäure, Meclofenaminsäure, Flufenaminsäure, Nifluminsäure, Tolfenaminsäure, Diflurisal, Flufenisal, Piroxicam, Sudoxicam, Isoxicam, pharmazeutisch annehmbare Salze davon und Mischungen davon.
  15. Verwendung der pharmazeutischen Zusammensetzung nach den Ansprüchen 1-14 zur Herstellung eines Medikaments zur Schmerzbehandlung eines menschlichen Patienten.
  16. Verwendung der pharmazeutischen Zusammensetzung nach den Ansprüchen 1-14 zur Herstellung eines Medikaments zur Verhütung des Mißbrauchs einer Hydrocodonformulierung.
  17. Die Verwendung von Hydrocodon oder eines pharmazeutisch annehmbaren Salzes davon bei der Herstellung einer Dosierungsform nach einem der Ansprüche 1-14.
  18. Die Verwendung von Naltrexon oder eines pharmazeutisch annehmbaren Salzes davon bei der Herstellung einer Dosierungsform nach einem der Ansprüche 1-14.
  19. Die Verwendung von Hydrocodon oder eines pharmazeutisch annehmbaren Salzes davon und Naltrexon oder eines pharmazeutisch annehmbaren Salzes davon bei der Herstellung einer Dosierungsform nach einem der Ansprüche 1-14.
EP04788669A 2003-09-25 2004-09-09 Pharmazeutische kombinationen von hydrocodon und naltrexon Active EP1663229B1 (de)

Priority Applications (5)

Application Number Priority Date Filing Date Title
PL04788669T PL1663229T3 (pl) 2003-09-25 2004-09-09 Farmaceutyczne kombinacje hydrokodonu i naltreksonu
SI200431458T SI1663229T1 (sl) 2003-09-25 2004-09-09 Farmacevtske kombinacije hidrokodona in naltreksona
EP10159824A EP2298303A1 (de) 2003-09-25 2004-09-09 Pharmazeutische kombinationen von hydrocodon und naltrexon
EP04788669A EP1663229B1 (de) 2003-09-25 2004-09-09 Pharmazeutische kombinationen von hydrocodon und naltrexon
CY20101100649T CY1110207T1 (el) 2003-09-25 2010-07-09 Φαρμακευτικοι συνδυασμοι υδροκοδωνης και ναλτρεξονης

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US50622203P 2003-09-25 2003-09-25
EP04788669A EP1663229B1 (de) 2003-09-25 2004-09-09 Pharmazeutische kombinationen von hydrocodon und naltrexon
PCT/US2004/029521 WO2005032555A2 (en) 2003-09-25 2004-09-09 Pharmaceutical combinations of hydrocodone and naltrexone

Publications (3)

Publication Number Publication Date
EP1663229A2 EP1663229A2 (de) 2006-06-07
EP1663229A4 EP1663229A4 (de) 2008-06-11
EP1663229B1 true EP1663229B1 (de) 2010-04-14

Family

ID=42664693

Family Applications (2)

Application Number Title Priority Date Filing Date
EP10159824A Withdrawn EP2298303A1 (de) 2003-09-25 2004-09-09 Pharmazeutische kombinationen von hydrocodon und naltrexon
EP04788669A Active EP1663229B1 (de) 2003-09-25 2004-09-09 Pharmazeutische kombinationen von hydrocodon und naltrexon

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP10159824A Withdrawn EP2298303A1 (de) 2003-09-25 2004-09-09 Pharmazeutische kombinationen von hydrocodon und naltrexon

Country Status (3)

Country Link
EP (2) EP2298303A1 (de)
PL (1) PL1663229T3 (de)
SI (1) SI1663229T1 (de)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015095391A1 (en) * 2013-12-17 2015-06-25 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2014306759B2 (en) 2013-08-12 2018-04-26 Pharmaceutical Manufacturing Research Services, Inc. Extruded immediate release abuse deterrent pill
US9492444B2 (en) 2013-12-17 2016-11-15 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill
EP3169315B1 (de) 2014-07-17 2020-06-24 Pharmaceutical Manufacturing Research Services, Inc. Missbrauchssichere flüssigkeitsfülldosierform mit unmittelbarer freisetzung
US9132096B1 (en) 2014-09-12 2015-09-15 Alkermes Pharma Ireland Limited Abuse resistant pharmaceutical compositions
US20160106737A1 (en) 2014-10-20 2016-04-21 Pharmaceutical Manufacturing Research Services, Inc. Extended Release Abuse Deterrent Liquid Fill Dosage Form

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Publication number Priority date Publication date Assignee Title
WO2015095391A1 (en) * 2013-12-17 2015-06-25 Pharmaceutical Manufacturing Research Services, Inc. Extruded extended release abuse deterrent pill

Also Published As

Publication number Publication date
EP2298303A1 (de) 2011-03-23
PL1663229T3 (pl) 2010-09-30
SI1663229T1 (sl) 2010-08-31
EP1663229A4 (de) 2008-06-11
EP1663229A2 (de) 2006-06-07

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